Primary Lens Set, 28D, 90D, 3 Mirror

GUDID 00841668144268

KATENA PRODUCTS, INC.

Ophthalmic diagnostic condensing lens
Primary Device ID00841668144268
NIH Device Record Keyb8ac3e58-ffb2-4dba-8b1c-3fe1ba958796
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimary Lens Set, 28D, 90D, 3 Mirror
Version Model NumberK31-3002
Company DUNS085668598
Company NameKATENA PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841668144268 [Primary]

FDA Product Code

HJLLens, condensing, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-19
Device Publish Date2024-04-11

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